Quality Cell Leader- Costa Rica- 2do Turno (3pm-12am)
CooperVision
Alajuela, Costa Rica
hace 5 días

JOB SUMMARY Supervise the activities related with Process Quality and Sterilization area : QA Final, Process Controls oversight and Sterilization / Backend (decanting) activities.

Lead the Process Flow Leader, Quality Control technicians and Direct Labor Operators in charge of the previous mentioned functions.

Accountable for :

  • Supervise QA Final Operators and Technicians
  • Supervise Sterilization / Decanting / Backend area and technicians
  • Monitor Process Performance and escalate issues as required
  • Provide direction to achieve Company Goals
  • Develop Personnel (Process Flow Leaders, Technicians and Operators)
  • Manage the segregation and disposition of non-conforming product
  • Assure Compliance with Laws and Regulations
  • Payroll Administration / Kronos
  • Monitor Procedure vs Practice adherence on the QA Final area
  • Promote adequate communication with other departments
  • Provide support on Quality issues identified in the Operations Area
  • Manage inventory control (Finish Goods, Work In process, Rework material)
  • Process and / or Equipment qualification / validation
  • POSITION QUALIFICATIONS

    KNOWLEDGE, SKILLS AND ABILITIES

  • Process Quality in a Medical Device Environment
  • Basic Statistical knowledge (Control Charts, Standard Deviation, Variation, Process Capability)
  • Excellent oral / written communications skills
  • Supervision skills (monitor daily performance, employee evaluations, perform training, assure Quality & Compliance in all activities within the area)
  • Perform non-conforming events investigations, including CAPA
  • Understanding, analysis and reporting of Quality Metrics
  • Ability to work with minimum supervision and take risk-based decisions.
  • Ability to negotiate with counterparts in order to make business balanced decisions
  • Provide guidance to assure compliance on Medical Device Regulations
  • Service oriented
  • WORK ENVIRONMENT

  • Work on a Production Area Environment
  • Require to move across the manufacturing room with frequent gowning and de-gowning process
  • Constant desktop work
  • Learn measurement techniques on different instruments like (OmniSpec, Optimec JCM, Dokumator)
  • Required to read high volume of documentation in Computer Monitor or Print information
  • Available to work on different shifts
  • EDUCATION

    Bachelor in Industrial Engineer or related field.

    EXPERIENCE

  • Minimum of 5 years in supervision functions
  • Minimum of 5 years of experience in the Medical Device or Pharmaceutical industry
  • Experience in problem solving activities.
  • Minimum of 3 years of experience in Process Quality Functions
  • Incoming Inspection experience (preferred)
  • Preferred CQE or equivalent certification, six sigma, lean process
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